U.S. patent number 10,533,949 [Application Number 14/774,114] was granted by the patent office on 2020-01-14 for test strip meter with a mechanism for pushing the test strip against an optical reader.
This patent grant is currently assigned to Ascensia Diabetes Care Holdings AG. The grantee listed for this patent is BAYER HEALTHCARE LLC. Invention is credited to Steven C. Charlton.
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United States Patent |
10,533,949 |
Charlton |
January 14, 2020 |
Test strip meter with a mechanism for pushing the test strip
against an optical reader
Abstract
The present invention relates to a system, method, and meter for
determining the concentration of an analyte in a fluid sample
provided on a test strip. The meter (10) may include a body (12),
an optical reader (28), and a test strip holder (90). The body (12)
has first (14) and second ends (16) and defines a longitudinal axis
y extending between the first and second ends (14,16). The optical
reader (28) may be coupled to the body (12) and adapted to analyze
the analyte on the test strip. The test strip holder (90) may be
coupled to the body (12) and include first and second arms (92,94).
One of the optical reader (28) or the test strip holder (90) may be
movable along the longitudinal axis of the body between a first
position, in which the first and second arms (92,94) of the test
strip holder (90) overlie the optical reader (28), and a second
position, in which the optical reader (28) extends beyond the first
and second arms (92,94) of the test strip holder (90). Such
configuration allows to push the test strip against the optical
reader (28). Pins (58, 60) are also disposed on the test strip
holder (90) to grasp the extremities of the test strip and stretch
said strip against the optical reader (28).
Inventors: |
Charlton; Steven C. (Osceola,
IN) |
Applicant: |
Name |
City |
State |
Country |
Type |
BAYER HEALTHCARE LLC |
Whippany |
NJ |
US |
|
|
Assignee: |
Ascensia Diabetes Care Holdings
AG (Basel, CH)
|
Family
ID: |
50389549 |
Appl.
No.: |
14/774,114 |
Filed: |
March 7, 2014 |
PCT
Filed: |
March 07, 2014 |
PCT No.: |
PCT/US2014/021691 |
371(c)(1),(2),(4) Date: |
September 09, 2015 |
PCT
Pub. No.: |
WO2014/164279 |
PCT
Pub. Date: |
October 09, 2014 |
Prior Publication Data
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|
|
Document
Identifier |
Publication Date |
|
US 20160025638 A1 |
Jan 28, 2016 |
|
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
61777614 |
Mar 12, 2013 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G01N
33/4875 (20130101); G01N 21/77 (20130101); G01N
2021/7759 (20130101) |
Current International
Class: |
G01N
21/77 (20060101) |
References Cited
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WO |
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WO 2014/164279 |
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Oct 2014 |
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WO |
|
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|
Primary Examiner: Siefke; Samuel P
Attorney, Agent or Firm: Dugan & Dugan, PC
Parent Case Text
The present application claims the benefit of the filing date of
U.S. Provisional Application No. 61/777,614, filed Mar. 12, 2013,
entitled METERS WITH MECHANISM FOR HANDLING SENSORS, the disclosure
of which is hereby incorporated herein by reference.
Claims
The invention claimed is:
1. A meter for determining a concentration of an analyte in a fluid
sample provided on a test strip, the meter comprising: a body
having first and second ends, the body defining a longitudinal axis
extending between the first and second ends; a read-head coupled to
the body and adapted to analyze the analyte on the test strip; and
a test strip holder coupled to the body, the test strip holder
having first and second arms, wherein the test strip holder is
movable relative to the body along the longitudinal axis of the
body between a first position, in which the first and second arms
of the test strip holder overlie the read-head, and a second
position, in which the read-head extends beyond the first and
second arms of the test strip holder.
2. The meter of claim 1, wherein the read-head is tapered.
3. The meter of claim 2, wherein the read-head is frustoconical in
shape.
4. The meter of claim 1, wherein the first and second arms are
oriented substantially parallel to each other and spaced apart from
one another so as to define a space therebetween, and wherein the
read-head includes a tapered portion, the tapered portion being at
least partially aligned with the space defined between the first
and second arms.
5. The meter of claim 1, wherein in the first position, the
read-head is substantially disposed within the body, and in the
second position, the read-head is substantially disposed outside
the body.
6. The meter of claim 1, wherein the test strip holder in the first
position is remote from the second end of the body, and in the
second position is adjacent the second end of the body.
7. The meter of claim 1, further comprising: a handling mechanism,
the handling mechanism comprising a first movable member and the
test strip holder; a first spring biasing the first movable member
remote from the second end, the first spring having a first spring
constant; and a second spring attached to one of the first or
second arms of the test strip holder and to the body, the second
spring having a second spring constant, wherein the first spring
constant is less than the second spring constant.
8. The meter of claim 1, further comprising a hinged cover having a
closed position over the test strip holder and having an open
position not over the test strip holder.
9. The meter of claim 1, wherein the read-head comprises an optical
read-head configured to illuminate a reagent pad on the test strip
and obtain measurement of nonspecular reflected light.
10. The meter of claim 1, wherein the meter further comprises: a
movable guide portion movably coupled to the body and movable along
the longitudinal axis between first and second guide positions,
wherein when the movable guide portion is in the first guide
position, the movable guide portion is remote from the second end
of the body, and when the movable guide portion is in the second
position, the movable guide portion is adjacent the second end of
the body, wherein the test strip holder is movably coupled to the
movable guide portion and at least partially disposed between the
movable guide portion and the body.
Description
BACKGROUND OF THE INVENTION
The quantitative determination of analytes in body fluids is of
great importance in the diagnoses and maintenance of certain
physiological abnormalities. For example, lactate, fructosamine,
cholesterol, bilirubin, alcohol, and drugs may be monitored or
tested in certain individuals. The monitored or tested body fluids
may include blood, interstitial fluid, saliva, or urine. In
particular, determining glucose in body fluids is important to
diabetic individuals who must frequently check the glucose level in
their body fluids to regulate the glucose intake in their
diets.
One manner of testing glucose levels is through the use of body
fluid containers that have reagents included in tape form. These
containers, however, have one or more disadvantages. For example,
one disadvantage of existing containers is that the test sensors or
test strips must be delivered from the container. In such
containers, the used sensors are not stored in the container and,
thus, may not allow for a convenient and/or safe disposal. Other
disadvantages of existing containers include not (a) adequately
providing protection against environmental moisture that degrades
the reagent and/or (b) keeping the reagent-sensing device
adequately clean and protecting it from wear and tear of normal
usage.
It would be desirable to provide a container that detects an
analyte concentration such as glucose that overcomes the
above-noted shortcomings.
BRIEF SUMMARY OF THE INVENTION
The present invention relates to systems and methods for
determining the concentration of an analyte in a fluid sample.
In one aspect of the presently disclosed embodiments, the system
includes a test strip and a meter.
The test strip has first and second ends, a first end portion
adjacent to the first end, a second end portion adjacent the second
end, and a central portion between the first and second end
portions and remote from the first and second ends. The central
portion of the test strip includes a reagent adapted to react with
an analyte in a fluid sample and to produce a reaction indicative
of the concentration of the analyte in the fluid sample. The first
and second ends of the test strip have first and second elongated
slots, respectively.
The meter has a body having first and second ends and defining a
longitudinal axis extending between the first and second ends.
Further, the meter includes a first movable portion movably coupled
to the body and movable along the longitudinal axis between a first
position, in which the first movable portion is adjacent the first
end of the body, and a second position, in which the first movable
portion is remote from the second end of the body. The meter also
includes a second movable portion movably coupled to the first
movable portion and at least partially disposed between the first
movable portion and the body. The second movable portion is movable
along the longitudinal axis between a first position, in which the
first movable portion is adjacent the first end of the body, and a
second position, in which the first movable portion is remote from
the second end of the body. The second movable portion has first
and second arms oriented substantially parallel to each other and
spaced apart from one another so as to define a space therebetween.
Further, the first and second arms have first and second slots,
respectively. Each of the first and second slots is dimensioned to
receive at least a portion of the test strip.
The meter further includes a read-head adapted to analyze the
reaction between the analyte and the reagent. The read-head has a
tapered read portion protruding from the second end of the body.
The tapered read portion is at least partially aligned with the
space defined between the first and second arms of the second
movable portion.
The meter further includes a first spring connected to the first
movable portion and biasing the first movable portion to the second
position. The first spring is partially disposed within the body
and having a first spring constant. The meter also includes a
second spring connected to the second movable portion and biasing
the second movable portion to the second position. The second
spring is partially disposed within the body and has a second
spring constant. The first spring constant is less than the first
spring constant.
The meter further has a cover pivotably coupled to the first
movable portion and movable between a closed position, in which the
cover is positioned over the tapered head of the read-head, and an
open position, in which the cover is not positioned over the
tapered head of the read-head. The cover has a covering portion and
connection portion. The covering portion is oriented substantially
perpendicular to the connection portion. The meter also has a hinge
pivotably connecting the connection portion of the cover to the
body.
In another aspect of the presently disclosed embodiments, the
system includes a test strip including a reagent adapted to react
with an analyte in a fluid sample and to produce a reaction
indicative of the concentration of the analyte in the fluid sample
and a meter. The meter includes a body having first and second
ends. The body of the meter defines a longitudinal axis extending
between the first and second ends. Further, meter includes a
read-head movably coupled to the body and adapted to analyze the
reaction between the analyte and the reagent. The read-head is
movable along the longitudinal axis of the body between a first
position, in which the read-head is substantially disposed within
the body, and a second position, in which the read-head is
substantially disposed outside the body.
In another aspect of the presently disclosed embodiments, a meter
is disclosed for determining the concentration of an analyte in a
fluid sample provided on a test strip. The meter can include a
body, a read-head, and a test strip holder. The body has first and
second ends and defines a longitudinal axis extending between the
first and second ends. The read-head may be coupled to the body and
adapted to analyze the analyte on the test strip. The test strip
holder may be coupled to the body and include first and second
arms. At least one of either the read-head or the test strip holder
may be movable along the longitudinal axis of the body between a
first position, in which the first and second arms of the test
strip holder overlie the read-head, and a second position, in which
the read-head extends beyond the first and second arms of the test
strip holder. In some embodiments both the read-head and the test
strip holder may move along the longitudinal axis. In other
embodiments, only the test strip holder or only the read-head may
move along the longitudinal axis.
The read-head may be tapered. In one embodiment, the read-head may
be frustoconical in shape.
The first and second arms of the test strip holder may be oriented
substantially parallel to each other and spaced apart from one
another so as to define a space therebetween. The read-head may
include a tapered portion that is at least partially aligned with
the space defined between the first and second arms.
The read-head may move along the longitudinal axis of the body.
When the read-head is in the first position, the read-head may be
substantially disposed within the body, and when the read-head is
in the second position, the read-head may be substantially disposed
outside of the body.
A movable base portion may be coupled to the body. The movable base
portion may be movable along the longitudinal axis between a first
base position, in which the movable base portion is adjacent the
first end of the body, and a second base position, in which the
movable base portion is remote from the first end of the body. In
some embodiments, the movable base portion may be coupled to the
read-head.
A first spring may be partially disposed within the body. The first
spring may bias the movable base portion toward the second end. The
second spring may be partially disposed within the body and bias
the movable base portion toward the first end. The first spring may
have a first spring constant that is different than the second
spring constant. In one embodiment, the first spring constant may
be less than the second spring constant of the second spring.
The test strip holder and the read head may move along the
longitudinal axis of the body. The first and second arms of the
test strip holder may be oriented substantially parallel to each
other and spaced apart from one another so as to define a space
therebetween. The read-head may include a tapered portion that is
at least partially aligned with the space defined between the first
and second arms. In one embodiment, the test strip holder may
instead be formed within the body. For example, the test strip
holder may be integrally formed with the body, such that the test
strip holder does not move relative to the body.
The meter can further include a movable guide portion movably
coupled to the body and movable along the longitudinal axis between
first and second guide positions. The movable guide portion is in
the first guide position when the movable guide portion is remote
from the second end of the body. The movable guide portion is in
the second position when the movable guide portion is adjacent the
second end of the body. The test strip holder may be movably
coupled to the movable guide portion and at least partially
disposed between the movable guide portion and the body.
In accordance with another aspect of the invention, a method for
determining the concentration of an analyte in a fluid sample
includes providing the fluid sample on a test strip; positioning
the test strip on a first member of a test meter so that a central
sample portion of the test strip is aligned with a central portion
of a read-head of the test meter; and moving at least one of the
first member or the read-head along a longitudinal axis extending
between first and second ends of the test meter so that the central
portion of the test strip contacts the top surface of the read-head
and the peripheral portions of the test strip contact a peripheral
edge surface of the read-head extending away from the top surface.
The test strip may include a reagent adapted to react with an
analyte in the fluid sample and to produce a reaction indicative of
the concentration of the analyte in the fluid sample. The central
portion of the test strip may be positioned between outer portions
of the test strip.
The first member may be moved between a first position, in which
the first member is remote from the second end of the body, and a
second position, in which the first member is adjacent the second
end of the body, the second end of the body being adjacent the
read-head.
The read-head may be moved between a first position, in which the
read-head is substantially disposed within the body, and a second
position, in which the read-head is substantially disposed outside
the body.
Another aspect of the presently disclosed embodiments includes a
system for determining the concentration of an analyte in a fluid
sample. The system includes a test strip and a test meter. The test
strip may include a reagent adapted to react with an analyte in a
fluid sample and to produce a reaction indicative of the
concentration of the analyte in the fluid sample. The meter may
include a body having first and second ends. The body may define a
longitudinal axis extending between the first and second ends. The
meter may further include a read-head movably coupled to the body
and adapted to analyze the reaction between the analyte and the
reagent. The read-head may be movable along the longitudinal axis
of the body between a first position, in which the read-head is
substantially disposed within the body, and a second position, in
which the read-head is substantially disposed outside the body. In
some embodiments, the read-head may have a tapered portion or may
be frustoconical in shape.
The body of the meter can further include first and second arms
oriented substantially parallel to each other and spaced apart from
one another so as to define a space therebetween. The read-head may
be at least partially aligned with the space defined between the
first and second arms of the body.
The first and the second arms of the test strip holder may have
first and second slots, respectively. Each of the first and second
slots can be dimensioned to receive at least a portion of the test
strip. The first and second slots may be oriented substantially
perpendicular to the longitudinal axis.
The meter may further comprise a movable base portion coupled to
the body and the read-head. The movable base portion may be movable
along the longitudinal axis between a first base position, in which
the movable base portion is adjacent the first end of the body, and
a second base position, in which the movable base portion is remote
from the first end of the body. When the movable base portion is in
the first base position, the read-head is in the first position.
When the movable base portion is in the second base position, the
read-head is in the second position.
The system may further include a first spring and a second spring.
The first spring may be partially disposed within the body, the
first spring biasing the movable base portion toward the second end
and having a first spring constant. The second spring may be
partially disposed within the body and bias the movable base
portion toward the first end. The second spring may have a second
spring constant and the first spring constant may be less than the
second spring constant.
These and other embodiments of the present disclosure are more
fully described hereinbelow.
BRIEF DESCRIPTION OF THE DRAWINGS
Various embodiments of the present invention will now be described
with reference to the appended drawings. It is appreciated that
that these drawings depict only exemplary embodiments of the
invention and are therefore not to be considered limiting of its
scope.
FIG. 1A is a schematic side view of a meter for determining the
concentration of an analyte in a fluid sample according to an
embodiment of the present invention;
FIG. 1B is a schematic front view of the meter of FIG. 1A;
FIG. 2A is a schematic side view of the meter of FIG. 1A with a
cover in an open position;
FIG. 2B is a schematic front view of the meter of FIG. 1A with the
cover in an open position;
FIG. 3 is a schematic top view of a test strip for use with the
meters described in the present invention;
FIGS. 4A, 4B, 5A, and 5B illustrate steps for operating the meter
shown in FIG. 1A;
FIG. 6A is a schematic side view of a meter for determining the
concentration of an analyte in a fluid sample according to an
embodiment of the present invention;
FIG. 6B is a schematic front view of the meter shown in FIG. 6A;
and
FIGS. 7A, 7B, 8A, 8B, 9A, 9B, 10A, and 10B illustrate steps for
operating the meter shown in FIG. 6A.
DETAILED DESCRIPTION
The present invention relates to systems, meters, and methods for
reading and handling test strips, such a test strips. FIGS. 1A and
1B depict an embodiment of a meter 10 for reading and handling test
strips adapted for determining the analyte concentration level in a
fluid sample. Although the following discussion describes the use
of test strips for determining the glucose concentration in blood,
the presently disclosed meter 10 may contain test strips designed
to determine the concentration of other analytes in other types of
samples. For example, test strips may alternatively measure
glucose, lipid profiles (e.g., cholesterol, triglycerides,
low-density lipoprotein (LDL) and high-density lipoprotein (HDL)),
microalbumin, hemoglobin A1c, fructose, lactate, bilirubin, or
other analytes. The analytes may be in, for example, a whole blood
sample, a blood serum sample, a blood plasma sample, or body fluids
like interstitial fluid (ISF) and urine.
The meter 10 includes a body 12 having a first end 14, a second end
16, and defining a longitudinal axis Y. The longitudinal axis Y
passes through the first and second ends 14 and 16 of the body 12.
The body 12 further has oppositely facing first and second
sidewalls 18 and 20 and front and rear walls 22 and 24. The first
and second sidewalls 18 and 20 and the front and rear walls 22 and
24 extend between the first and second ends 14 and 16 of the body
12.
In addition to the body 12, the meter 10 includes a read-head 28
adapted to analyze the reaction between the analyte and the reagent
on a test strip. The read-head 28 may be an optical read-head
configured to illuminate a reagent pad (specimen) on a test strip
and obtain the measurement of nonspecular reflected light. The
read-head 28 is mounted on the second end 16 of the body 12 and may
include a substantially planar base 30 and a substantially tapered
or frustoconical read portion 32. The substantially planar base 30
of the read-head 28 may be disposed within a slot 34 of the body
12. The slot 34 of the body 12 may be located within a
substantially central portion of the second end 16 remote from the
first and second sidewalls 18 and 20. The substantially planar read
portion 32 of the read-head 28 protrudes away from the second end
16 of the body 12 in a direction opposite of the first end 14 of
the body along the longitudinal axis Y.
The meter 10 further includes a mechanism 26 for handling test
strips, such as test strips and sensors in a tape form. The
handling mechanism 26 includes a first movable member 36 movably
coupled to the body 12. The first movable member 36 can move
relative to the body 12 along the longitudinal axis Y between a
first position and second position. In the first position, the
first movable member 36 is remote from the second end 16 of the
body 12, as shown in FIG. 1B. In the second position, the first
movable member 36 is adjacent the second end 16 of the body 12, as
illustrated in FIG. 5B.
The first movable member 36 may include first and second sliding
arms 38 and 40 adapted to slide along the sidewalls 18 and 20 of
the body 12, respectively. Specifically, the first sliding arm 38
can slide along a recess 42 formed on at least a portion of the
first sidewall 18 of the body 12. Similarly, the second sliding arm
40 can slide along a recess 44 formed on at least a portion of the
second sidewall 20 of the body 12. Each of the first and second
sliding arms 38 and 40 may include a first sliding rail 46 adapted
to slide along a second sliding rail 48 disposed along the sidewall
(18 or 20). The sliding rails 46 and 48 collectively form a guiding
mechanism 50 adapted to guide the movement of the sliding arm (38
or 40) along the sidewall (18 or 20). The meter 10 may
alternatively include other kinds of guiding mechanisms capable of
guiding the movement of the sliding arms 38 and 40 relative to the
sidewalls 18 and 20 of the body 12.
The first movable member 36 further includes first and second
securing arms 52 and 54 adapted to secure a test strip to a second
movable member, as discussed in detail below. The first securing
arm 52 extends substantially perpendicular from the first sliding
arm 38 toward the read-head 28. The second securing arm 54 extends
substantially perpendicular from the second sliding arm 40 toward
the read-head 28. The first and second securing arms 52 and 54 are
substantially parallel to each other and may span along a common
longitudinal axis X. However, the first and second securing arms 52
and 54 are spaced apart from each other so as to form a space 56 or
aperture therebetween. The space 56 is dimensioned to receive at
least a portion of the read-head 28.
The first and second securing arms 52 and 54 include securing pins
58 and 60, respectively. Each of the securing pins 58 and 60 may
have a tapered configuration and extend substantially perpendicular
from an end of the respective securing arm 52 or 54 adjacent to the
space 56. As discussed in detail below, the securing pins 58 and 60
aid in securing a test strip to the meter 10.
The first movable member 36 further includes first and second
elongated members 62 and 64, such as tubes or rods, partially
positioned within the body 12. The first and second elongated
members 62 and 64 may have any suitable cross-section, such as
square, circular, oval, etc. The first elongated member 62 extends
substantially perpendicular from the first securing arm 52, while
the second elongated member 64 extends substantially perpendicular
from the second securing arm 54. The first elongated member 62 is
dimensioned to be slidably positioned within a first elongated
opening or bore 66 of the body 12. The second elongated member 64
is dimensioned to be slidably positioned within a second elongated
opening or bore 68 of the body 12.
The first and second elongated openings 66 and 68 are substantially
parallel to each other and each extends from the second end 16 of
the body 12 to a location between the first and second ends 14 and
16 of the body 12. Each of the first and second elongated openings
66 and 68 has a respective first portion 70 and 72 adjacent to the
second end 16 of the body 12 and a respective second portion 74, 76
remote from the second end 16 of the body 12. The cross-sectional
area or diameter of the first portion 70 of the opening 66 is
larger than the cross-sectional area of the second portion 74.
Similarly, the cross-sectional area of the first portion 72 of the
opening 68 is larger than the cross-sectional area of the second
portion 76. A shoulder 78 may divide the first and second portions
70 and 74 of the opening 66. Likewise, a shoulder 80 may divide the
first and second portions 72 and 76 of the opening 68.
The handling mechanism 26 further includes a biasing member, such
as a spring 82, for biasing the first movable member 36 toward its
first position remote from the second end 16 of the body 12. The
spring 82 is connected to the first elongated member 62 and may be
disposed within the second portion 74 of the opening 66. Thus, the
second portion 74 of the opening 66 is dimensioned to receive the
spring 82.
The handling mechanism 26 includes another biasing member, such as
a spring 84, for biasing the first movable member 36 toward its
first position remote from the second end 16 of the body 12. The
spring 84 is connected to the second elongated member 64 and is
disposed within the second portion 76 of the opening 68. Hence, the
second portion 76 of the opening 68 is dimensioned to receive the
spring 84.
The handling mechanism 26 further includes a second movable member
90 connected to the body 12 and movable along the longitudinal axis
Y between a first position remote from the second end 16 of the
body 12 (FIG. 1A) and a second position adjacent the second end 16
of the body 12 (FIG. 5B). The second movable member 90 can move
independently of the first movable member 36 and includes first and
second arms 92 and 94 adapted to hold a test strip, such as a test
strip. Despite this independent motion capability, the second
movable member 90 may abut the first movable member 36 at least
when located in its second position.
The first and second arms 92 and 94 of the second movable member 90
are oriented substantially parallel to each other and may be
positioned along a common longitudinal axis Z. However, the first
and second arms 92 and 94 are spaced apart from each other so as to
form a space or aperture 96 therebetween. The space 96 is
dimensioned to receive at least a portion of the read-head 28.
The first arm 92 of the second movable member 90 may be attached to
the body 12 via a biasing member, such as spring 98, at least
partially disposed within the first portion 70 of the opening 66.
An end of the spring 98 may rest on (or be mounted on) the shoulder
78 of the opening 66. The spring 98 is stronger or stiffer than
spring 82. In other words, the spring constant (according to
Hooke's law of elasticity) of spring 98 is higher than the spring
constant of spring 82. Thus, the first movable member 36 displaces
a larger distance toward the second end 16 of the body 12 relative
to the displacement of the second movable member 90 upon
application of the same force to first and second movable members
36 and 90.
The second arm 94 of the second movable member 90 may be attached
to the body 12 via a biasing member, such as spring 100, at least
partially disposed within the first portion 72 of the opening 68.
An end of the spring 100 may rest on (or be mounted on) the
shoulder 80 of the opening 68. The spring 100 is stronger or
stiffer than spring 84. In other words, the spring constant
(according to Hooke's law of elasticity) of spring 100 is higher
than the spring constant of spring 84. Thus, the first movable
member 36 displaces a larger distance toward the second end 16 of
the body 12 relative to the displacement of the second movable
member 90 upon application of the same force to first and second
movable members 36 and 90.
Each of the first and second arms 92 and 94 of the second movable
member 90 has slots 102 and 104, respectively. Each of the slots
102 and 104 is dimensioned to receive at least a portion of a test
strip, such as a test strip, and may extend along longitudinal axis
Z. Each of the first and second arms 92 and 94 further has
respective holes 106 and 108. The holes 106 and 108 are dimensioned
to receive securing pins 58 and 60, respectively. The holes 106 and
108 may be oriented substantially orthogonal to the longitudinal
axis Z and substantially parallel to the longitudinal axis Y.
The meter 10 further includes a lid or cover 110 pivotally coupled
to the handling mechanism 26. The cover 110 can move between a
closed position (FIG. 1A), in which the cover is positioned over
the read-head 28, and an open position (FIG. 2A), in which the
cover is not positioned over the read-head 28. The cover 110 may
include connection portion or lip 112 pivotally connected to the
first movable member 36 and a covering portion 114 extending
substantially perpendicular from an end of the connection portion
112. The covering portion 114 overlies the read-head 28 when the
cover 110 is in the closed position and therefore protects the
read-head 28 from environmental contamination. A hinge 116 or any
other device or mechanism suitable for establishing a pivotal
connection couples the connecting portion 114 of the cover 110 to
the first movable member 36 of the handling mechanism 26. These
pivotal connections allow the cover 110 to move between a closed
position (FIG. 1A), in which the covering portion 114 overlies the
read-head 28 and therefore protects the read-head from
environmental contamination, and an open position (FIG. 2A,2B), in
which the covering portion does not overlie the read-head 28.
FIG. 3 shows a test strip or test strip 120 for use with meter 10.
In some embodiments, the test strip 120 may be a top fill test
strip. In other embodiments, the test strip 120 may be other types
in tape form. In the embodiment shown in FIG. 3, the test strip 120
defines a longitudinal axis A along its length and may have first
and second elongated slots 122 and 124 substantially in-line with
each other. Both elongated slots 122 and 124 extend through the
thickness of the test strip 120 and may be positioned along the
longitudinal axis A. The first elongated slot 122 is adjacent the
first end 126 of the test strip 120, whereas the second elongated
slot 124 is adjacent the second end 128 of the test strip 120. The
test strip 120 also has a reaction area 130 containing one or more
reagents for reacting with an analyte of interest in a fluid
sample. The reaction area 130 is located within a central region
132 of the test strip 120 remote from the first and second ends 126
and 128. In one example, the test strip 120 may be 28.3 millimeters
long and 4 millimeters wide. The test strip 120 may also be
dimensioned differently.
In operation, the test strip 120 and the meter 10 collectively form
a system for determining the concentration of an analyte in a fluid
sample. Initially, the cover 110 of the meter 10 may be in a closed
position, as shown in FIGS. 1A and 1B. Before placing the test
strip 120 in the meter 10, the cover 110 is moved from the closed
position to the open position, as seen in FIGS. 2A and 2B, to
uncover the second movable member 90. The cover 110 may be moved to
the open position by pivoting it 180 degrees as seen in FIGS. 2A
and 2B. With the cover 110 in its open position, the test strip 120
is placed within the slots 102 and 104 of the second movable member
90, as shown in FIGS. 4A and 4B.
With continued reference to FIGS. 4A and 4B, the first and second
movable members 36 and 90 are then moved from their first position
toward their second position by urging or pushing the first and
second movable members toward the second end 16 of the body 12
along arrow A. A user may urge the first and second movable members
36 and 90 toward their second position through application of force
on the cover 110. While moving the first and second movable members
36 and 90 from the first position to the second position, the first
movable member approaches the second movable member 90 because the
springs 82 and 84 are weaker than the springs 98 and 100 connected
to the second movable member. As a result, the securing pins 58 and
60 of the first movable member 36 can pass through the holes 106
and 108 of the second movable member 90 and the slots 122 and 124
of the test strip 120 while the first and second movable members
move from the first to the second position, thereby securing the
test strip to the meter 10, as seen in FIGS. 5A and 5B.
As seen in FIGS. 5A and 5B, continued movement of the first and
second movable members 36 and 90 toward the second end 16 of the
body 12 urges the reaction area 130 of the test strip 120 against
the read-head 28 of the meter 10. Also, while moving the first and
second movable members 36 and 90 from the first position to the
second position, the securing pins 58 and 60 slide outwardly along
the slots 122 and 124 of the test strip 120 toward the ends 126 and
128 of the test strip 120. When the securing pins 58 and 60 reach
the outward ends of the slots 122 and 124 of the test strip 120,
the test strip 120 is maintained in tension and the reaction area
130 of the test strip 120 is pressed against the read-head 28 of
the meter 10.
The first and second movable members 36 and 90 may be secured in
their second position adjacent the second end 16 of the body with
any suitable securing mechanism or device (not shown). In one
exemplary embodiment, the securing mechanism includes a latch
attached to the cover 110 and spring-loaded catch attached adjacent
the first end 14 of the body 12.
Once the first and second movable members 36 and 90 are in their
second positions, as shown in FIGS. 5A and 5B, a fluid sample may
be deposited on the reaction area 130 of the test strip 120 to
determine the concentration of an analyte in that fluid sample in
the conventional manner. After testing the fluid sample, the test
strip 120 can be removed from the second movable member 90 before
moving the cover 110 back to its closed position. Alternatively,
the cover 110 may be moved to its closed position with the test
strip 120 with the test strip inside the meter 10. In this case,
the test strip 120 may be disposed of at a later time.
In the embodiment described above, the read-head 28 remains
stationary relative to the body 12 of the meter 10, while the test
strip 120 moves toward the read-head. In other embodiments,
however, the read-head moves toward the test strip, while the test
strip remains stationary relative to the body of the meter.
FIGS. 6A-7B illustrate meter 200 having handling mechanism 226 that
allows a read-head 228 to move relative to the test strip 120,
while the test strip remains stationary relative to the body 212 of
the meter 200. The body 212 of the meter 200 defines a longitudinal
axis B along its length. The longitudinal axis B extends between
oppositely facing first and second ends 214 and 216 of the body
212.
The body 212 of the meter 200 has first and slots 302 and 304
adjacent its second end 216. Each of the slots 302 and 304 is
dimensioned to receive at least a portion of the test strip 120.
The first and second slots 302 and 304 may be oriented
substantially perpendicular to the longitudinal axis B and are
spaced apart from each other so as to form a space or opening 256
therebetween. The opening 256 leads to an open cavity 211 of the
body 212. The open cavity 211 is dimensioned to receive at least a
portion of the handling mechanism 226 and the read-head 228.
The body 212 of the meter 200 further has holes 306 adjacent the
slot 302 and holes 308 (FIG. 7B) adjacent the slot 304. The holes
306 and 308 may be substantially parallel to the longitudinal axis
B.
The read-head 228 is dimensioned to fit within the open cavity 211
and includes a substantially tapered or frustoconical read portion
232 and a substantially cylindrical portion 231. In some
embodiments, the read-head 228 may be an optical read-head
configured to illuminate a reagent pad (specimen) on a test strip
and obtain the measurement of nonspecular reflected light.
Moreover, the read-head 228 is mounted on a support base 230 and
can move relative to the body 212 of the meter 200 along the
longitudinal axis B. The read-head 228 is fixed to the support base
230 and therefore moves in unison with the support base.
The support base 230 is part of the handling mechanism 226 and can
move along the longitudinal axis B between a first position, in
which the read-head 228 is entirely or substantially disposed
within the open cavity 211, as seen in FIG. 6B, and a second
position, in which the entire or a substantial portion of the read
portion 232 of the read-head 228 is positioned outside the open
cavity 211, as shown in FIG. 10B. Further, the support base 230 may
include a support portion 233 having a substantially flat bottom
surface and first and second elongated support members 238 and 240.
The substantially flat bottom surface of the support portion 233
may be oriented substantially orthogonal to the longitudinal axis
B. The first and second elongated support members 238 and 240 may
each have a substantially L-shape, as seen in FIG. 7A.
The meter 200 further includes lid or cover 310 pivotally coupled
to the first and second elongated support members 238 and 240. The
cover 310 may include a lip or connection portion 312 pivotally
connected to the first and second elongated support members 238 and
240 and covering portion 314 extending substantially perpendicular
from an end of the connection portion 312. In one embodiment, a
hinge 316 may pivotally connect an end of the first elongated
support member 238 to an end of the cover 310. Similarly, a hinge
(not shown) may pivotally connect an end of the second elongated
support member 240 to another end of the cover 310. Although the
figures depict hinges pivotally connecting the cover 310 to the
first and second elongated support members 238 and 240, any
suitable device or mechanism, such as a pivot pin, may pivotally
couple the cover to the first and second elongated support members.
These pivotal connections allow the cover 310 to move between a
closed position as shown in FIG. 7A, in which the covering portion
314 overlies the read-head 228 and therefore protects the read-head
from environmental contamination, and an open position as seen in
FIG. 8A, in which the covering portion does not overlie the
read-head.
A calibration or reference standard 311 may be attached to an inner
portion of the cover 310. The calibration standard may face the
read-head 228 and can provide a known reflectance level for
calibrating or checking that the optics are clean and not
contaminated with blood or any other fluid. If the reaction
sequence does not allow the standard to be measured before the test
(e.g., blood glucose test), it can be measured after the next
analysis.
The handling mechanism 226 includes first and second guiding
elongated members 262 and 264 along which the support base 230 can
slide. The support base 230 may be a substantially H-shaped. The
first and second guiding elongated members 262 and 264 may be a
tube or a rod or any other type of elongated structure. The
cross-section of the first and second elongated members 262 and 264
may have different shapes, such as oval, square, rectangular,
circular, etc. Regardless, the first and second elongated members
262 and 264 can move along the longitudinal axis B and the
read-head 228 can move along the guiding members 262 and 264 of the
meter 200. In some embodiments, the first and second guiding
elongated members 262 and 264 may be spaced apart and substantially
parallel to each other. The first end 263 of the first guiding
elongated member 262 is dimensioned to be positioned and slide
within an opening or bore 265 of the body 212. Similarly, the first
end 267 of the second guiding elongated member 264 is dimensioned
to be positioned and slide within an opening or bore 269 of the
body 212. The openings 265 and 269 are in communication with the
open cavity 211.
Body hole opening 302 is smaller than the diameter of second end of
the first guiding elongated member 262 and thus limits movement of
elongated member 262 towards second end. A first securing pin 258
may have a tapered tip and protrudes from the second end 259 of the
first guiding elongated member 262 toward the second end 216 of the
body 212. Moreover, the first securing pin 258 is dimensioned to be
received within the holes 306 of the body 212 to secure at least a
portion of a test strip 120 positioned in the slots 302 and
304.
Body hole opening 308 is smaller than the diameter of second end of
the first guiding elongated member 264 and thus limits movement of
elongated member 262 towards second end. A second securing pin 260
may have a tapered tip and protrudes from the second end 261 of the
second guiding elongated member 264. In addition, the second
securing pin 260 is dimensioned to be received within the holes 308
to secure at least a portion of a test strip 120 positioned in the
slots 302 and 304.
A first mechanical stop or divider 270 is disposed around the outer
periphery of the first guiding elongated member 262 adjacent the
second end 259. Further, the first mechanical stop 270 separates a
first biasing element or spring 272 from a second biasing element
or spring 274. The first and second spring 272 and 274 may be both
positioned around the first guiding elongated member 262. The
second spring 274 biases the first guiding elongated member toward
the first end 214 of the body 212, whereas the first spring 272
biases the support base 230 toward the second end 216 of the body.
The first spring 272 is stiffer than the second spring 274.
A second mechanical stop or divider 276 is disposed around the
outer periphery of the second guiding elongated member 264 adjacent
the second end 261. Moreover, the second mechanical stop 276
separates a third biasing element or spring 278 from fourth biasing
element or spring 280. The third and fourth springs 278 and 280 may
be both positioned around the second guiding elongated member 264.
The fourth spring 280 biases the second guiding elongated member
264 toward the first end 214 of the body 212, while the third
spring 278 biases the support base toward the second end 216 of the
body 212. The third spring 278 is stiffer than the fourth spring
280.
In use, the meter 200 can be used to handle a test strip or test
strip 120. During operation, the cover 310 is moved from the closed
position, as seen in FIG. 7A, to the open position, as shown in
FIG. 8A, to expose the slots 302 and 304 and the read-head 228. The
test strip 120 is then placed within the slots 302 and 304, as
depicted in FIG. 8B.
Once the test strip 120 has been placed within the slots 302 and
304, the support base 230 is urged away from the first end 214 of
the body 212 against the influence of the first and second springs
272 and 274, and third and fourth springs 278 and 280 (i.e., toward
its second position) as seen in FIGS. 9A and 9B. The support base
230 may be moved via the cover 310. While the support base 230
moves toward its second position, the read-head 228 moves toward
the test strip 120 against springs one, two three and four. As
second and fourth springs 274 and 280 are weaker than first and
second springs 272 and 278, first and second guiding elongated
members 262 and 264 move first towards second end 216 where the
first and second securing pins 258 and 260 enter holes 306 and 308,
respectively. Movement of first guiding elongated member 262 ceases
when second end 259 is excluded by the smaller opening of hole 308.
Movement of second guiding elongated member 264 ceases when second
end 261 is excluded by the smaller opening of hole 308. Continued
movement of the support base 230 away from the first end 214 of the
body causes the read-head 228 to slide along first and second
guiding elongated member 262 and 264 against first and third
springs 272 and 278 and push at least the reaction area 130 of the
test strip 120 past the second end 216 of the body 212, as shown in
FIGS. 9A and 9B.
As the first and second securing pins 258 and 260 enter holes 306
and 308, respectively, the first and second securing pins 258 and
260 pass through slots 122 and 124 of the test strip 120, thereby
securing the test strip to the meter 200. While the support base
230 continues to move away from the first end 214 of the body 212,
the first and second securing pins 258 and 260 move along the slots
122 and 124 of the test strip 120 from the inner ends of the slots
to the outer ends of the slots. The support base 230 should be
moved away from the first end 214 of the body 212 until the support
base 230 reaches its second position, as shown in FIGS. 10A and
10B. At this point, the test strip 120 is pressed against the
read-head 228, and a substantial portion of the read-head 228 is
disposed outside the open cavity 211.
The support base 230 may be locked in its second position by any
suitable locking mechanism. For example, a spring-loaded latch may
be attached to the cover 310 and a catch may be attached to the
body 212 near its first end 214. The latch may be configured to
hook onto the catch and maintain the support base 230 (through the
cover 310) in its second position.
A fluid sample, such as blood, may then be deposited on the
reaction area 130 of the test strip 120 to determine the
concentration of an analyte in that fluid sample. After testing the
fluid sample, the test strip 120 can be removed from the slots 302
and 304 before moving the cover 110 back to its closed position.
Alternatively, the cover 110 may be moved to its closed position
with the test strip 120 inside the meter 10. In this case, the test
strip 120 may be disposed of at a later time.
Some embodiments of the present disclosure are further described in
the paragraphs below.
Alternative Embodiment A
A system for determining the concentration of an analyte in a fluid
sample, comprising:
a test strip having first and second ends, a first end portion
adjacent to the first end, a second end portion adjacent the second
end, and a central portion between the first and second end
portions and remote from the first and second ends, the central
portion of the test strip including a reagent adapted to react with
an analyte in a fluid sample and to produce a reaction indicative
of the concentration of the analyte in the fluid sample, the first
and second ends having first and second elongated slots,
respectively;
a meter having a body having first and second ends and defining a
longitudinal axis extending between the first and second ends, the
meter comprising:
a first movable portion movably coupled to the body and movable
along the longitudinal axis between a first position and second
position;
a second movable portion movably coupled to the first movable
portion and at least partially disposed between the first movable
portion and the body;
a read-head adapted to analyze the reaction between the analyte and
the reagent, the read-head having a tapered read portion protruding
from the second end of the body;
a first spring connected to the first movable portion and biasing
the first movable portion to the second position;
a second spring connected to the second movable portion and biasing
the second movable portion to the second position; and
a cover pivotably coupled to the first movable portion and movable
between a closed position.
Alternative Embodiment B
The system of embodiment A, wherein when the first movable portion
is in the first position, the first movable portion is adjacent the
first end of the body.
Alternative Embodiment C
The system of embodiment B, wherein when the first movable portion
in the second position, the first movable portion is remote from
the second end of the body.
Alternative Embodiment D
The system of embodiment A, wherein the second movable portion is
movable along the longitudinal axis between a first position and a
second position.
Alternative Embodiment E
The system of embodiment D, wherein when the second movable portion
is in the first position, the first movable portion is adjacent the
first end of the body
Alternative Embodiment F
The system of embodiment E, wherein when the second movable portion
is in the second position, the first movable portion is remote from
the second end of the body.
Alternative Embodiment G
The system of embodiment F, wherein the second movable portion has
first and second arms oriented substantially parallel to each other
and spaced apart from one another so as to define a space
therebetween.
Alternative Embodiment H
The system of embodiment G, wherein the first and the second arms
having first and second slots, respectively, each of the first and
second slots being dimensioned to receive at least a portion of the
test strip.
Alternative Embodiment I
The system of embodiment G, wherein the tapered read portion is at
least partially aligned with the space defined between the first
and second arms of the second movable portion.
Alternative Embodiment J
The system of embodiment A, wherein the first spring is partially
disposed within the body and has a first spring constant.
Alternative Embodiment K
The system of embodiment J, wherein the second spring is partially
disposed within the body and has a second spring constant, the
first spring constant being less than the first spring
constant.
Alternative Embodiment L
The system of embodiment A, wherein the cover has a covering
portion and connection portion, the covering portion being oriented
substantially perpendicular to the connection portion.
Alternative Embodiment M
The system of embodiment A, wherein when the cover is in a closed
position, the cover is positioned over the tapered head of the
read-head.
Alternative Embodiment N
The system of embodiment M, wherein when the cover is in an open
position, the cover is not positioned over the tapered head of the
read-head.
Alternative Embodiment O
The system of embodiment A, further comprising a hinge pivotably
connecting the connection portion of the cover to the body.
Alternative Embodiment P
A system for determining the concentration of an analyte in a fluid
sample, comprising:
a test strip including a reagent adapted to react with an analyte
in a fluid sample and to produce a reaction indicative of the
concentration of the analyte in the fluid sample; and
a meter including a body having first and second ends, the body
defining a longitudinal axis extending between the first and second
ends, the meter further comprising: a read-head movably coupled to
the body and adapted to analyze the reaction between the analyte
and the reagent, the read-head being movable along the longitudinal
axis of the body between a first position, in which the read-head
is substantially disposed within the body, and a second position in
which the read-head is substantially disposed outside the body.
It will be appreciated that that the various features set forth
herein can be combined in different ways than presented in the
present description. It will also be appreciated that the features
described in connection with individual embodiments may be shared
with other of the described embodiments.
Although the invention herein has been described with reference to
particular embodiments, it is to be understood that these
embodiments are merely illustrative of the principles and
applications of the present invention. It is therefore to be
understood that numerous modifications may be made to the
illustrative embodiments and that other arrangements may be devised
without departing from the spirit and scope of the present
invention as defined by the appended claims.
* * * * *